Porous Load Sterilisation Processes; Cycle Development and Validation
Involved from the beginning of this project has enabled us to get the URS right and manage performance throughout the lifecycle. Cycle development completed following IOQ and PQ to commence May 2019. Qualification using Kaye Validator 2000 and 1/0.3mm thermocouples to get the correct response and accuracy required for porous load.
VPHP Bio decontamination Cycle for Sterility Test and Aseptic Filling isolators
Consistency of VPHP cycles and ensuring qualification of an operational window is critical for Annex 15 compliance and successful PQ and RQ of the system. Working with Tim Coles we have the capability to advise on cycle development and qualification as well as deliver the qualification protocols and execution.
Fridges, Freezers, Incubators on Biotech facility. SIA, QCA’s and CPP’s
Delivering the Risk Based approach to qualification for Fridges, Freezers, Incubators (CO2, Humidity Control) for a Biotech site in Ireland. Annex 15 Requirement to ensure qualification is based upon a documented and justified risk assessment applies to Fridges, Freezers and Incubators used in production/QC also. MTL Projects have established Risk Assessment procedures starting from System Impact Assessment (SIA) standard questions Based upon this the Quality Critical Attributes (QCA’s) at that part of the process, then the Critical Process Parameters (CPP’s) and their ranges can be defined.
This approach is standard for all Direct Impact systems but is often overlooked for equipment such as Fridges, Freezers and Incubators, however there are generally significant advantages in the increased understanding that this approach brings; in the future handling deviations, OOS’s but also at the qualification stage looking at potential for equivalency testing and also leveraging data. Our Current project includes detailed SIA, QCA’s and CPP’s analysis and review of product dossier to define the qualification approach.